FDA Approves Controversial Diet Drug Despite Warning of Suicide Risk

Contrave has terrible side effects, is expensive, includes a hidden antidepressant, and barely even works. So why did the FDA approve it? Action Alert!

The FDA approved two weight loss drugs in 2012, Qsymia and Belviq, but sales have been sluggish. This week FDA approved Contrave, even though the FDA initially denied approval to Contrave in 2011 due to health concerns—increased blood pressure and rapid pulse. Rather than addressing the safety issues, the manufacturer simply commissioned another study, which seems to have been enough for FDA to green-light the drug.

Contrave is the combination of two drugs: naltrexone, which is an opioid receptor antagonist used primarily in the management of alcohol and opioid dependence, and bupropion, an antidepressant (marketed as Wellbutrin). In other words, it is a repackaging of old drugs that have no direct link to appetite or eating. It carries the same black box warning as other antidepressants about the risk of causing suicidal thoughts. The black box warnings do not mention violence to others, although there is evidence of that too. Not to mention over-excitement and headaches.

Even with the threat of suicide and/or violence, not to mention the blood pressure and pulse dangers, it’s not as if this drug is a weight-loss powerhouse. From the evidence, it appears to be a dud. In clinical trials, non-diabetic patients taking Contrave lost only 4.1 percent more weight than those taking placebos. Only 42% of those getting Contrave lost more than 5% percent of their weight; in the placebo group, 17% lost the same amount. That means Contrave really worked to a small degree for only 25% of all patients. With this drug, a two-hundred-pound man would have lost only ten pounds over the course of a year. (Results from an earlier clinical trial that enrolled patients with type 2 diabetes showed that patients had an average loss of only 2% more weight with Contrave than with a placebo, and only worked on 18% of patients.)

Another weight-loss drug, rimonabant (known by the trade names Acomplia and Zimulti), also caused suicidal thinking and depression, even though it doesn’t contain antidepressants. In this case, the drug maker, the French company Sanofi SA, touted it as a possible “blockbuster” drug to treat obesity, with only mild side effects. In 2007 an FDA advisory panel urged the agency to reject rimonabant because of a significant increase in “suicidality” in patients. European regulators had approved the use of rimonabant prior to the FDA panel’s action, but sales were later suspended. It also spurred a class-action lawsuit from investors, who sued Sanofi for concealing clinical trials revealing the drug’s dangers. The lawsuit was settled this month for $40 million.

One in three Americans is obese, so naturally the drug companies see a potential bonanza. But obesity drugs have not made anything close to the “blockbuster” profits that manufacturers expected. The company that makes Qsymia is trying new tactics, such as direct-to-consumer advertising, and offering the first two weeks of pills for free.

The desperation to boost drug sales could also be why the FDA classified obesity as a disease in 2000, and the American Medical Association and the Obesity Society followed suit more recently. It could also be why vested interests are pushing legislation (the “Treat and Reduce Obesity Act”) to expand Medicare’s coverage of obesity drugs. Once insurance covers the major portion of the cost of the drugs, their sales are bound to increase. There is also a petition before the FDA to forbid supplements from making any weight loss reference, a petition that the agency hasn’t responded to but could at any time. If you haven’t done so already, write to the FDA and tell them not to ban weight loss supplements. Please take action immediately!

Although nutritional supplement companies cannot make claims to treat obesity now that it’s considered a disease, their labels can still refer to the promotion of normal amounts of weight loss. Terms like “suppresses appetite” or “increases satiety” are barely permissible, so long as it is made clear that the product is for ordinary weight loss and not for the treatment of obesity. For a review of supplements, please see LEF.org.

Natural approaches to weight management—nutrition, exercise, lifestyle changes, supplements—are safer and far more effective. But apparently our government would rather have a whole nation of potentially suicidal, FDA-drug-addicted zombies with high blood pressure, so long as Big Pharma is able to rake in the dollars.

The FDA approved this drug because it was TOLD to approve it. What most people don’t realize is that the FDA does NO TESTING on its own; it relies solely on the test results it is given. OF COURSE any drug company will skew the results in its favor–then the FDA rubberstamps the okay and approval. And with the FDA OWNED by Monsanto and Big Pharma, can any of us honestly believe that they are really “protecting” us from anything?!

Kay Beams

This is just shameful. Contrave has terrible side effects, is expensive, includes a hidden antidepressant, and barely even works. So why did the FDA approve it? Because Big Money wanted it and got what they wanted. Dirty, bribery money is rampant in our government, and it is so unacceptable and unjustifiable and illegal. Policies nor bills nor any issues coming out of the government should NOT be allowed to be influenced by MONEY. Shame on you all.

Natasha Gubert

please stop approving drugs, especially blockbuster drugs that are developed to make money
not really help people. Please get the lobbyists out of your organization and tear out the
revolving door. We are tired of being harmed by drugs. When will your agency start acting
to protect the public instead of working for wall street?

george sigler

They are being paid off. When the FDA approved Aspertame (sic), the scandal that followed forcedseveral of the FDA members to resign and they were, of course, then hired by…Monsanto. We’re on our own folks as far as staying healthy.

Don’t Ban The diet pills every body body is not the same that is when you go get check by your doctor let them tell you if it is safe for you! You need to be in good health.

Margaret Johnson

I’d like to know the efficacy of any drug and who is making the money off the drug. It’s not right or honorable to sell a drug that has shown so little efficacy and so much danger with so little available information on the package. It seems that it’s giving the Manufacturers a way to make more money even if the drug they’re selling has no value. So the Mfg made a bad drug. They’ve got to admit it and dump it. Not relable it sell it. They can and will make better drugs that do the job they are intended to. But they will also make drugs that are poor or worse. That’s the cost of business. It’s wrong to relable a bad drug and sell it anyway just to make their bank balance look better.

CityguyUSA

“it is a repackaging of old drugs”, as are most drug. A molecule of difference is considered enough to re-brand and sell to the public as a new medication while keeping the patent intact for another 20 years.

How can natural cures receive FDA approval ?
No money in it. No patents. No regard for human life.

Guy Barnes

Well, the FDA is SQUARELY Iin the back pockets of the clowns at the FDA. How, in ALL that is commonsense can this drug be approved KNOWING of the negative affects ( suicide and physical assault on this drug. MONEY TALKS, and the general public is at risk of this, apparently, midn-altering drug.

Just how callous, uncaring, and downright bought-off can this, or any government get? Unfortunately, there is no depth of big pharma’s pocketbook or the FDA’s pocket.

Due to your “rules” I can’t say EXACTLY what I have in mind.

Steve Dickheiser

I so often wonder whose side the FDA is on and we shouldn’t have to wonder. We should know they are on our side but the Corporations always win over us with the FDA. I do NOT trust the FDA and I haven’t for decades but more and more as time goes on.

Shasha

HI, LDN in that dose may hurt the liver of people if it is for a long time. LDN is used usallly at 3-4.5mg, not 35mg. Wellbutrin may not interfer with sex so they may offer that. People can lose weight due to eating no wheat in the Wheat Belly book….about 25 pounds in the first month. Gluten may be like Heroin and cause cravings. Once they stop this drug. gluten may hurt them. Lower their immune system and destroy their gut lining so nutrients don’t absorb. The Celiac diet, not drugs may help. LDN may help block hidden gluten but in extremely low dose. No gluten (wheat/barley/rye…oats)..no dairylsoy/sugar/GMO may help many health issues of the brain/body heal. Depression /weight and more health issues may be helped in a cheap safe way without this new drug.

Hunter R

Wow an opiate antagonist and an antidepressant combination,Both drugs have a high percentage of Suicidal ideation and actually acting behavior of suicide,This is a very dangerous drug and to use the side effect of the Naltreoxone and Wellbutrin as the primary force in Wt. control is not only ridiculous but out right dangerous. Also if this is such a good drug for a much cheaper price we can use both as generics and pay significantly less for the medication.. Why Contrave it is obvious money talks and we all have to walk into poverty. Hunter

There is another probable cause for weight gain & inability to lose even when calorie intake is reduced. The plethora of vaccines – they make changes in our immune systems in order to work, which affects the liver & other components of our digestion & energy storage. It might also be linked to the type of preservative used in manufacturing some of the vaccines. Some have binding properties according to some physicians & other health professionals I’ve spoken with. I rarely get flu & other vaccines now, after noticing significant weight gain immediately afterwards, even though I didn’t change my eating habits. Of course there are lifestyle factors as well – in general we are less active than we were a few decades ago, but one should be able to lose weight on 1000-1500 calories per day!

Many weight loss drugs are introduced into the market each day. Obesity has become a serious health concern. People just blindly going for this weigh loss pills. Most of the time side effects of the drug is neglected. and it looks like FDA also liberal on these drugs.. Hope FDA brings better policies regarding these weght loss products.